Sannuo Biotech (300298.SZ): Continuous glucose monitoring system obtained EU MDR certification

According to Zhitong Finance App, Sannuo Biotech (300298.SZ) announced that the company recently received a notice from TÜV Rheinland, Germany. The new “continuous glucose monitoring system” product independently developed by the company has obtained EU Medical Regulation Devices (EU) 2017/745 (“MDR”) certification.

New certified products are now: Sinocare iCAN Continuous Glucose Monitoring System (Model: i6, H6, i7, H7); GlucoMen® iCAN Continuous Glucose Monitoring System (Model: H6).

The new continuous glucose monitoring system product certified this time (that is, the company's second-generation CGM product) is an upgrade to the continuous glucose monitoring system product (that is, the company's first-generation CGM product) that has previously obtained MDR certification in September 2023. The company's second-generation CGM products were upgraded to an integrated structural design on the premise that the core technology did not change. There was no need for users to assemble sensor kits and emitter kits, improving the ease of use by users. At the same time, the wearing components of second-generation products are significantly reduced in diameter and thickness compared to first-generation products, and the size is reduced by more than 60% compared to first-generation products, improving user comfort. In addition, this approval has further expanded the application scenarios of the company's two generations of CGM products: 1. On the basis that the wearing part for people of all applicable ages (2 years and above) is the abdomen, the wearing area of people aged 13 and above is extended to the upper arm or abdomen to meet the wearing habits of different users; 2. In addition to the iCAN CGM App, users can choose iCAN View Glucose Data Reader as the second main display device, which can better meet the needs of European health insurance for CGM products; 3. Suitable for the company's development Reinforcement stickers for both generations of products have been approved, and users can choose whether to use reinforcements to meet the needs of different scenarios.